MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	DXW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Discomfort (2330)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The dxw150 model intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye).Patient was not happy with her near vision.A soft contact trial was conducted and patient had better near vision.Patient also indicated blurry vision significantly interferes with her daily activities.Iol explant was scheduled for (b)(6) 2025 however, the patient rescheduled the procedure for (b)(6) 2025.No further information is available.
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: unknown/asked information was not provided.Section d-6b date explanted: not applicable as the iol remains implanted; therefore, not explanted.Section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: upon further review, it was noted the section h-6 health effect - clinical code 2138 unexpected postop refraction reported in the initial mdr was incorrect.Therefore, this supplemental filing is to correct the health effect clinical code that was incorrectly reported.The following fields have been updated accordingly: section h-6 health effect - clinical code: 2330 - dissatisfaction with near vision.Previously reported code was 2138.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 21532394
• Report Number: 3012236936-2025-000064
• Device Sequence Number: 15466328
• Product Code: HQL
• UDI-Device Identifier: 05050474762848
• UDI-Public: (01)05050474762848(17)260612
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2026
• Device Model Number: DXW150
• Device Catalogue Number: DXW150U135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White